Mixed but encouraging results for Lilly's donanemab in Alzheimer's

Over the weekend, US pharma major Eli Lilly (NYSE: LLY) released new data on its investigational intravenous drug donanemab, indicating that it could slow the cognitive decline of patients with Alzheimer's disease, thus creating hope in an area of medicine research that has so far produced mostly a string of failures.

Presented at the 15th International Conference on Alzheimer's & Parkinson Diseases held virtually March 9-14, and published simultaneously in the  New England Journal of Medicine (NEJM), results from the Phase II TRAILBLAZER-ALZ study expand on previously reported top-line data that found donanemab met its primary endpoint and showed significant slowing of decline on the integrated Alzheimer's Disease Rating Scale (iADRS), a composite measure of cognition and daily function, in patients with early symptomatic Alzheimer's disease compared to placebo.

Additionally, data from secondary analyses showed donanemab consistently slowed cognitive and functional decline, with ranges between 20%-40% in all secondary endpoints [Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13), Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living (ADCS-iADL), Mini-Mental State Examination (MMSE)] with nominal statistical significance at multiple times compared to placebo. Further, prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer's disease.